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About
The primary objective of this study is to assess the efficacy of cannabidiol oral solution on hyperphagia-related behavior in patients with Prader-Willi Syndrome (PWS). The secondary objectives of this study are to assess the efficacy, safety and tolerability, impact on quality of life, and impact on physical activity of cannabidiol oral solution in patients with PWS.
Enrollment
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Volunteers
Inclusion criteria
Participant and/or parent(s)/caregiver(s) fully comprehend the informed consent form and assent form, understand all study procedures, and can communicate satisfactorily with the investigator and study coordinator, in accordance with applicable laws, regulations, and local requirements.
Participants with a genetically confirmed diagnosis of Prader-Willi Syndrome using standard deoxyribonucleic acid methylation test or fluorescent in situ hybridization. Documentation of genetically confirmed diagnosis of Prader-Willi Syndrome is acceptable.
A score of ≥10 on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT).
A caregiver is available to complete the HQ-CT.
If female, is either not of childbearing potential (defined as premenarchal or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing one of the following medically acceptable methods of birth control:
Adequate renal function, defined as serum creatinine ≤ 1.5*upper limit of normal (ULN) and urine protein/creatinine ratio ≤0.4. The Investigator may deem the participant eligible if he or she judges the laboratory values to be not clinically significant.
Adequate hepatic function, defined as total bilirubin ≤ 1.5*ULN and aspartate aminotransferase and alanine aminotransferase levels ≤ 3*ULN.
Growth hormone treatment will be permitted if doses have been stable for at least 1 month prior to screening.
Psychotropic treatment will be permitted and should be stable at least 6 weeks prior to screening.
Any other treatment including thyroid hormones should be stable for at least 6 weeks prior to screening.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
7 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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